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Top FDA Drug Approvals in 2015: Multiple Myeloma

Bristol-Myers and AbbVie have teamed up to add a new weapon to the fight against multiple myeloma.

Developed by Bristol-Myers Squibb(NYSE:BMY) and AbbVie(NYSE:ABBV) Empliciti is the new kid on the cancer treatment block. It works in conjunction with existing drug therapies to more effectively treat multiple myeloma.

In this video segment, The Motley Fool's Kristine Harjes and Todd Campbell walk through some of the results of the clinical trials, and process how Empliciti could take on an integral role in standard drug therapy for multiple myeloma in the near future.

A full transcript follows the video.

This podcast was recorded on Dec. 2, 2015.

Kristine Harjes: So our last drug that we wanted to talk about today is called Empliciti, and it is developed by Bristol-Myers and AbbVie, and that was just approved a few days ago -- Nov. 30.

Todd Campbell: Yeah, you know, Empliciti is important because, again, if you look at indication: Is there a need? There is. Empliciti treats multiple myeloma, and it's been approved for use alongside two very commonly used therapies for multiple myeloma -- Dexamethasone and Revlimid. And because it's being approved as an adjunct therapy, and it is being approved as adjunct therapy to these widely used drugs, there's a very good chance in my view that it becomes part of the standard of care in the second, and definitely in the third-line treatment for patients.

And since we're talking about 28,000 or so, I think, patients, or 26,000 patients that get diagnosed with multiple myeloma every year, a lot of whom who won't respond, will have to get retreated. I think that this, again, is going to be a very important drug because it put up very solid efficacy during trials.

Harjes: Yeah, this is a really devastating disease. About 11,000 people die from it every year. And so to get drugs that work better and better is a fantastic thing. And it's a huge market too. I mean the multiple myeloma market is expected to rise in value from $8.9 billion in 2014 to just over $22 billion by 2023.

Revlimid is a huge part of that. That's a Celgene(NASDAQ:CELG) drug. Sales should top about $5.6 billion this year, and you're going to see Revlimid continue to be used, especially because Empliciti is being used alongside it. Just to dig into a couple of the numbers from the trials: 78.5% of patients taking the Empliciti combination therapy, meaning alongside Dexa and Revlimid, saw complete or partial tumor shrinkage which was better than the 65.5% reported in just the Dexa and Revlimid arm. So clearly this is a statistically significant improvement.

Campbell: Yeah, and you've got almost a 5-month advantage in progression-free survival as well by adding that third drug to this cocktail. Revlimid is the most widely used in second-line therapy. It won approvals for first-line therapy early this year. It's getting more widely used there. Theoretically, there could be label-expansion opportunities that would move this combination into the first-line therapy. There could be use of it off-label in the first line. We don't know how that's going to shake out.

But as you mentioned, it's a huge marketplace. I mean, you've got Revlimid at $5.6 billion in sales. You've got Velcade, which is also another widely used drug in the first and second line of treating this disease. That's a $3 billion a year drug. You've got Pomalyst, which is a third-line drug also made by Celgene. That's selling at a billion-dollar pace a year. It's really hard for me to look at the numbers for progression-free survival and tumor shrinkage and not think that doctors are going to want to use this standard-of-care. And then of course, it just comes down to what we talked about before, which is, will payers pay for it?

Harjes: Indeed. Yeah, I mean this is not a cheap drug. It's going to be $10,000 a month as compared to Revlimid's $14,000 and Velcade's $9,000. And it's a "me too." You're using it alongside the current therapies, so it's just making things even more expensive.

Talking about numbers if you're curious about what the impact could be on the companies that developed this drug, Bristol in the United States will get 70% of the profit from Empliciti, AbbVie will get the other 30%. Ex-U.S., it looks like Bristol is going to pay AbbVie a royalty. So this is definitely more of a needle-mover for Bristol than for AbbVie.